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Aliskiren for Geriatric Lowering of Systolic Hypertension: a randomized controlled trial

Journal of Human Hypertension volume 24, pages 600–608 (2010)Cite this article

Abstract

Efficacy and safety of the direct renin inhibitor aliskiren was compared with ramipril for treatment of essential systolic hypertension in elderly patients. A 36-week, randomized, double-blind, parallel-group, active-controlled, optional-titration study was performed in 901 patients (aliskiren, n=457; ramipril, n=444) ⩾65 years of age with systolic blood pressure (SBP) ⩾140 mm Hg. Aliskiren 150–300 mg per day or ramipril 5–10 mg per day for was administered for 12 weeks with optional add-on therapy of hydrochlorothiazide (12.5–25 mg per day) at week 12 and amlodipine (5–10 mg per day) at week 22. The primary end point was non-inferiority of aliskiren vs ramipril monotherapy for change from baseline in mean sitting SBP (msSBP) at week 12. Decreases from baseline msSBP and mean sitting diastolic BP with aliskiren monotherapy (−14.0 and −5.1 mm Hg, respectively) were non-inferior (P<0.001 for both values) and superior to ramipril monotherapy (−11.6, −3.6 mm Hg; P=0.02, P<0.01, respectively). More patients achieved BP control with aliskiren (42%) than ramipril (33%; P<0.01). At week 36, fewer patients receiving aliskiren-based therapy required add-on treatment with hydrochlorothiazide or amlodipine (P=0.01 and 0.048, respectively). Tolerability was similar, but more patients receiving ramipril reported cough (P<0.001). In elderly patients with systolic hypertension, aliskiren proved to be more effective and better overall anti-hypertensive therapy compared to ramipril.

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Acknowledgements

This study was funded by Novartis Pharma AG, Basel, Switzerland. Novartis was represented on the trial steering committee in the study design, analysis and interpretation of data. The sponsor provided study drug preparations. Editorial assistance was provided by Complete Healthcare Communications Inc. (Chadds Ford, PA, USA) and supported by Novartis Pharmaceuticals Corporation.

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Authors and Affiliations

  1. Cardiovascular Division, Medical School, University of Minnesota, Minneapolis, MN, USA

    D A Duprez

  2. Department of Pharmacotherapy, College of Pharmacy, University of Utah, Salt Lake City, UT, USA

    M A Munger

  3. Novartis Pharma AG, Basel, Switzerland

    J Botha

  4. Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA

    D L Keefe & A N Charney

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  1. D A Duprez
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  2. M A Munger
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  4. D L Keefe
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Correspondence to D A Duprez.

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Competing interests

DA Duprez has received support for research studies or advisory boards or speaker's bureau honoraria from Novartis, Sanofi-Aventis, Roche, Merck, Schering-Plough, Pfizer and Forest Laboratories. MA Munger has received support for research studies from Novartis. J Botha is an employee of Novartis Pharma AG (Basel, Switzerland). DL Keefe and AN Charney are employees of Novartis Pharmaceuticals Corporation (East Hanover, NJ, USA).

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This paper was presented in abstract form at the 2008 American Heart Association Annual Scientific Sessions.

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Duprez, D., Munger, M., Botha, J. et al. Aliskiren for Geriatric Lowering of Systolic Hypertension: a randomized controlled trial. J Hum Hypertens 24, 600–608 (2010). https://doi.org/10.1038/jhh.2009.107

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